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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBVI 1% OVD (formerly BD 1% OVD and Biolon)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAltacor , Ltd.
Merlin House, Brunel Rd.
Theale RG7 4AB
PMA NumberP960011
Supplement NumberS029
Date Received02/12/2018
Decision Date03/15/2018
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revisions to the labeling trade name from BVI 1% OVD® (1% sodium hyaluronate viscoelastic surgical aid fluid) to BIOLON, distributor, and Instructions for Use for the inclusion of a tamper-evident tip cap closure system.
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